FDA-Device2021-04-14Class II
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
Hologic, Inc
Hazard
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
Sold states
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CT, DC, FL, GA, HI, IL, IN, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NY, OH, OR, PA, TX, UT, VA, VT, WA, WI, WV and the countries of Austria (AT), Belgium (BE), France (FR), Germany (DE), Great Britain (GB), Italy (IT) Netherlands (NL), Spain (ES), Switzerland (CH),, Canada (CA), Hong Kong (HK), Australia (AU), New Zealand (NZ).
Affected count
1355 kits
Manufactured in
10210 Genetic Center Dr, N/A, San Diego, CA, United States
Products
Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2021Don't want to check this manually?
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